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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) (K863094)Em Diagnostic Systems, Inc.1986-08-29
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY (K862407)Ciba Corning Diagnostics Corp.1986-08-29
BUN (RATE) REAGENT (K863196)Sigma Diagnostics, Inc.1986-08-26
ELECTROPHORESIS WORK CENTER (EWC) (K861414)Helena Laboratories1986-08-26
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG) (K861386)Eastman Kodak Company1986-08-26
SERACON(TM) CAL (PRODUCT NO. DO35) (K862594)Bhp Diagnostix, Inc.1986-08-19
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 (K862453)Em Diagnostic Systems, Inc.1986-08-19
SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA (K862439)Boots-Celltech Diagnostics, Inc.1986-08-19
ICON READER (K862956)Hybritech, Inc.1986-08-19
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95 (K862525)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95 (K863002)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 (K862707)Em Diagnostic Systems, Inc.1986-08-19
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY (K862818)American Dade1986-08-19
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT (K862834)Diagnostic Chemicals, Ltd. (Usa)1986-08-19
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY (K862428)American Dade1986-08-19
KING DIAGNOSTICS LDH TEST (K862306)King Diagnostics, Inc.1986-08-19
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 (K862704)Em Diagnostic Systems, Inc.1986-08-19
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT (K862833)Diagnostic Chemicals, Ltd. (Usa)1986-08-19
RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL (K862871)Cambridge Medical Technology1986-08-19
ENZYMUN-TEST HCG (K862108)Boehringer Mannheim Corp.1986-08-19
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM (K862359)E.I. Dupont DE Nemours & Co., Inc.1986-08-19
WAKO MICRO TP (K861508)Wako Chemicals USA, Inc.1986-08-19
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95 (K862706)Em Diagnostic Systems, Inc.1986-08-19
ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT (K860823)Cis-Us, Inc.1986-08-19
DOUBLE ANTIBODY ESTRADIOL RIA KIT (K862603)Diagnostic Products Corp.1986-08-19
SURESPOT (K862701)Helena Laboratories1986-08-19
MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT (K862832)Diagnostic Chemicals, Ltd. (Usa)1986-08-12
GLUCOFACTS DATA MANAGEMENT SYSTEM (K861844)Miles Laboratories, Inc.1986-08-12
GLUCOFACTS DATA PRINTER (K861779)Miles Laboratories, Inc.1986-08-08
DIATRON BLOOD GLUCOSE METER (K855178)Dextron, Inc.1986-08-04
CHEMVARION(TM) (K862586)G.B.F. Industries, Inc.1986-08-04
GAS-TRAK (K862278)United Diagnostics, Inc.1986-08-04
CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (K862542)Supelco, Inc.1986-08-04
UTAK-STABBS TOXICOLOGY CONTROL (K862420)Utak Laboratories, Inc.1986-08-04
DIAGEM 300 BG REAGENT STRIPS (K854329)Seton Products, Inc.1986-08-04
TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER (K862206)Micromedic Systems1986-08-04
FORETEL, COLOR OVULATION TEST (K860828)Nms Pharmaceuticals, Inc.1986-08-04
CHEMTROL(TM) (K862587)G.B.F. Industries, Inc.1986-08-04
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95 (K862703)Em Diagnostic Systems, Inc.1986-08-04
PARAMAX LIPASE REAGENT (K862440)American Dade1986-08-04
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL (K862185)Bio-Rad1986-08-04
DART AMYLASE-D.S. REAGENT SYSTEM (K862370)Coulter Electronics, Inc.1986-08-01
TWIN GOT-AST IFCC/GPT-ALT IFCC (K861792)Boehringer Mannheim Corp.1986-07-29
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS (K862247)V-Tech, Inc.1986-07-29
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) (K861703)Leeco Diagnostics, Inc.1986-07-29
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT (K862300)Amresco, Inc.1986-07-29
RIGHT-DAY URINARY LH (EIA) (K860538)Leeco Diagnostics, Inc.1986-07-29
DU PONT DRUG CALIBRATOR (K861786)E.I. Dupont DE Nemours & Co., Inc.1986-07-29
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR (K862506)Millipore Corp.1986-07-29
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (K862255)Sterling Diagnostics, Inc.1986-07-29
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS (K862262)Serono Diagnostics, Inc.1986-07-29
LIQUID CHROMATOGRAPHY COLUMNS (K862541)Supelco, Inc.1986-07-29
ANALYST ANALYTICAL TEST ROTORS (K862274)E.I. Dupont DE Nemours & Co., Inc.1986-07-29
ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS (K861733)Kyoto Diagnostics, Inc.1986-07-25
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY (K861797)Nichols Institute Diagnostics1986-07-22
TRIGLYCERIDES (K862033)Pointe Scientific, Inc.,1986-07-22
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT (K862019)Beckman Instruments, Inc.1986-07-18
ICS APOLIPOPROTEIN B REAGENT TEST KIT (K862386)Beckman Instruments, Inc.1986-07-18
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) (K862507)Sclavo, Inc.1986-07-16
HEMAFLUOR REAGENT KIT (K860309)Helena Laboratories1986-07-14
ISOPURE LC SYSTEM (K862178)The Perkin-Elmer Corp.1986-07-14
MICROMEDIC HTSH MONOCLONAL IRMA KIT (K860813)Micromedic Systems1986-07-14
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) (K860815)Diagnostic Products Corp.1986-07-11
REFLOTRON URIC ACID (K861831)Boehringer Mannheim Corp.1986-07-11
DELFIA (TM) HCG KIT (K862044)Lkb Instruments, Inc.1986-07-11
KING DIAGNOSTICS URIC ACID TEST (K862208)King Diagnostics, Inc.1986-07-08
TDX REA LACTIC ACID (K861741)Abbott Laboratories1986-07-07
VANILMANDELIC ACID (VMA) REAGENT SET (K861962)Sterling Diagnostics, Inc.1986-07-07
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II (K861756)Texas Immunology, Inc.1986-07-07
HBDH (OPTIMIZED) REAGENT (K862319)Sigma Chemical Co.1986-07-07
DIRECT ACU-SLIDE TEST (K861212)Cal-Tech Diagnostics, Inc.1986-07-07
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT (K862180)Clinetics Corp.1986-07-07
HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY (K862083)Hygeia Sciences1986-07-02
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER (K861303)Miles Laboratories, Inc.1986-07-02
CLINIFACTS 200 DATA MANAGEMENT SYSTEM (K861778)Miles Laboratories, Inc.1986-07-02
GLUCOMETER M BLOOD GULCOSE METER (K855202)Miles Laboratories, Inc.1986-07-02
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED (K860999)Ciba Corning Diagnostics Corp.1986-07-02
V-TREND EIA TSH (K861918)V-Tech, Inc.1986-07-02
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT (K860924)Monoclonal Antibodies, Inc.1986-07-02
CHLORIDE PROCEDURE (K861674)Data Medical Associates, Inc.1986-07-01
HCG IRMA, CAT. NO. CR-1501 (K862007)Pacific Biotech, Inc.1986-07-01
BLOOD UREA NITROGEN (BUN) PROCEDURE (K861666)Data Medical Associates, Inc.1986-07-01
INORGANIC PHOSPHORUS PROCEDURE (K861661)Data Medical Associates, Inc.1986-07-01
CHOLESTEROL CALIBRATORS (K861314)Sigma Diagnostics, Inc.1986-07-01
AMYLASE PROCEDURE (K861664)Data Medical Associates, Inc.1986-07-01
BICARBONATE PROCEDURE (K861673)Data Medical Associates, Inc.1986-07-01
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704 (K861696)Boehringer Mannheim Corp.1986-07-01
UNISKAN II (K861897)Flow Laboratories, Inc.1986-07-01
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (K862256)Sterling Diagnostics, Inc.1986-07-01
TRIGLYCERIDE (TRINDER) PROCEDURE (K861670)Data Medical Associates, Inc.1986-07-01
CREATININE PROCEDURE (K861655)Data Medical Associates, Inc.1986-07-01
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS (K862299)Amresco, Inc.1986-07-01
UREA NITROGEN (GLDH) REAGENT SET (UV) (K862210)Sterling Diagnostics, Inc.1986-07-01
SOMAS LIQUID URINE CONTROL (K862179)Somas Medical Industries, Inc.1986-07-01
ENZYMUN TEST TBG (K862109)Boehringer Mannheim Corp.1986-06-30
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) (K861387)Eastman Kodak Company1986-06-27
SUCROSEP HUMAN PROLACTIN (HPR) IRMA (K861271)Boots-Celltech Diagnostics, Inc.1986-06-27
TOTAL BILIRUBIN TEST KIT (K861998)Ciba Corning Diagnostics Corp.1986-06-27
TSH IRMA KIT (K862249)Pacific Biotech, Inc.1986-06-27
TWIN TRIGLYCERIDES GPO/CHOLESTEROL (K861793)Boehringer Mannheim Corp.1986-06-27
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